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Sleep Harmonization Via Bundled Team-Based Interventions in the ICU

Study acronym: SHANTI-ICU
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults. Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design. The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality. Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.
Trial Details
NCT Number NCT07840560
Lead Sponsor University of California, San Diego
Collaborators: Patient-Centered Outcomes Research Institute, Johns Hopkins University, Massachusetts General Hospital, University of California, San Francisco, University of Utah, Vanderbilt University Medical Center, University of Puerto Rico, AdventHealth Orlando, Baylor University
Conditions Sleep Deprivation, Critical Illness, Sleep-Wake Disorders, Bundle Care, Implementation Science, Delirium
Enrollment 62,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov